Method of performing a sphenopalatine ganglion block procedure

ABSTRACT

Methods and devices to quickly and accurately locate the sphenopalatine ganglion (SPG) while performing a sphenopalatine ganglion block procedure that introduces a medication to the SPG. The methods and devices also prevent the medication applied to the SPG from flowing down a patient&#39;s throat during the procedure.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a Continuation of U.S. application Ser. No.14/699,999 filed Apr. 29, 2015 and entitled STABILIZED SURGICAL DEVICEFOR PERFORMING A SPHENOPALATINE GANGLION BLOCK PROCEDURE, which claimsthe benefit of Continuation-In-Part of U.S. application Ser. No.14/572,353 filed Dec. 16, 2014 and entitled SURGICAL DEVICE FORPERFORMING A SPHENOPALATINE GANGLION BLOCK PROCEDURE, which claims thebenefit of and priority to Continuation-In-Part of U.S. application Ser.No. 14/298,521 filed Jun. 6, 2014 and entitled SURGICAL DEVICE FORPERFORMING A SPHENOPALATINE GANGLION BLOCK PROCEDURE, which claims thebenefit of and priority to, under 35 U.S.C. §119(e), U.S. ProvisionalApplication Ser. No. 61/917,097, filed Dec. 17, 2013, entitledAPPARATUS, SYSTEM, AND METHOD FOR TREATING HEADACHES, which are herebyincorporated herein by reference in their entireties for all that theyteach and for all purposes.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to devices, methods and systemsfor treating headaches and cerebral neurovascular disorders, and morespecifically, to devices, such as a surgical device, and methods forusing such device, for delivering medication to the sphenopalatineganglion.

BACKGROUND

The sphenopalatine ganglion (SPG) is a collection (or bundle) of nervesthat is located in a bony cavity within an individual's skull. Thecavity is called the pterygopalatine fossa (or sphenopalatine fossa).There is an SPG and corresponding sphenopalatine fossa located on eachside of the skull.

The SPG and sphenopalatine fossa are accessible via an individual'snasal cavity. Individuals who suffer from pain associated with headachesand/or facial aches may elect to undergo a procedure referred to as asphenopalatine ganglion block, which is a procedure that includes theapplication of a medication, such as anesthetic, by a trainedprofessional to the SPG. Some of the conventional techniques forperforming a sphenopalatine ganglion block procedure, however, areunpleasant to the individual. For example, upon application of themedication to the SPG, a large majority of the medication may flow downthe individual's throat. Additionally, the medication is typicallydistasteful, which further exacerbates the unpleasantness. Furthermore,typical devices used to perform a sphenopalatine ganglion blockprocedure may not have the ability to accurately locate the SPG withoutthe use of large external imaging systems, such as x-ray systems.

SUMMARY

Accordingly, there is a need for a device, method and/or system such asa surgical device that has the capability to quickly and accuratelylocate the SPG while performing a sphenopalatine ganglion blockprocedure, as well as prevent the medication applied to the SPG fromflowing down a patient's throat. The present disclosure discusses amethod and device that satisfies such needs.

The method may include delivering a medication to a sphenopalatineganglion of a patient comprising the steps of inserting a device into anasal cavity of a patient through a nostril, wherein the devicecomprises a handle comprising a proximal end and a distal end, aninflation device at least partially and integrally disposed within thehandle, a flexible tubular member extending from the distal end of thehandle, the flexible tubular member comprising a proximal end, a distalend, an inflation lumen coupled to the plunger and extending from theproximal end of the flexible tubular member, and a second lumenextending from the proximal end of the flexible tubular member to aport, an expandable member attached to the flexible tubular member, theexpandable member comprising a proximal end and as distal end, whereinthe inflation lumen opens into the expandable member, wherein the portis disposed proximally of the proximal end of the expandable member, andan illumination device disposed adjacent the distal end of the flexibletubular member and distally of the expandable member, and activating theillumination device, placing the expandable member adjacent thepatient's choana, expanding the expandable member adjacent the patient'schoana, introducing a medication to sphenopalatine ganglion through theport in the flexible tubular member, removing at least a portion of themedication from the port in the flexible tubular member, collapsing theexpandable member, and removing the device from the nasal cavity.

A device in accordance with this disclosure for accurately locating theSPG, while performing a sphenopalatine ganglion block procedure, and/orfor preventing the medication applied to the SPG from flowing down apatient's throat, may include a handle comprising a proximal end and adistal end, an inflation device at least partially and integrallydisposed within the handle, a flexible tubular member extending from thedistal end of the handle, the flexible tubular member comprising aproximal end, a distal end, an inflation lumen coupled to the plungerand extending from the proximal end of the flexible tubular member, anda second lumen extending from the proximal end of the flexible tubularmember to a port, an expandable member attached to the flexible tubularmember, the expandable member comprising a proximal end and as distalend, wherein the inflation lumen opens into the expandable member,wherein the port is disposed proximally of the proximal end of theexpandable member, and an illumination device disposed adjacent thedistal end of the flexible tubular member and distally of the expandablemember.

The device may also or alternatively include a switch on the handle foractivating the illumination device.

The device may also or alternatively include a pressure relief valvedisposed within the handle and coupled to the plunger and the inflationlumen.

Accordingly, another device for delivering a medication to a patient inaccordance with this disclosure may comprise a handle comprising aproximal end and a distal end, an inflation device at least partiallyand integrally disposed within the handle, a flexible tubular memberextending from the distal end of the handle, the flexible tubular membercomprising a proximal end, a distal end, an inflation lumen extendingfrom the proximal end, a second lumen extending from the proximal end toa port disposed proximally of the distal end of the flexible tubularmember, an expandable member attached to the flexible tubular member,wherein the inflation lumens opens into the expandable member, whereinthe port is disposed proximally of the expandable member, and a pressurerelief valve disposed within the handle and coupled to the plunger andthe inflation lumen.

An alternative device in accordance with this disclosure for use inperforming a sphenopalatine ganglion block or other type of medicalprocedure while insuring that the device is only used once and/or on asingle patient, may include a handle comprising a proximal end and adistal end, an inflation device at least partially and integrallydisposed within the handle, a flexible tubular member extending from thedistal end of the handle, the flexible tubular member comprising aproximal end, a distal end, an inflation lumen coupled to the plungerand extending from the proximal end of the flexible tubular member, anda second lumen extending from the proximal end of the flexible tubularmember to a port, an expandable member attached to the flexible tubularmember, the expandable member comprising a proximal end and as distalend, wherein the inflation lumen opens into the expandable member,wherein the port is disposed proximally of the proximal end of theexpandable member, an illumination device disposed adjacent the distalend of the flexible tubular member and distally of the expandablemember, a temporary power supply disposed within the handle, and a meansfor depleting the power supply within a predetermined time.

The temporary power supply for the device may include a battery. Themeans for depleting the power supply in a predetermined time may includea circuit having a second circuit path in parallel with a first circuitpath for the illumination device. The device may also or alternativelyinclude a pull tab for interrupting the circuit, thereby creating anopen circuit for either or both the first circuit path and the secondcircuit path.

An alternative device in accordance with this disclosure for use inperforming a sphenopalatine ganglion block or other type of medicalprocedure may include a handle comprising a proximal end and a distalend, an inflation device at least partially and integrally disposedwithin the handle, the inflation device comprising a plunger and abarrel, the barrel comprising a wall forming a chamber and an openingthrough the wall, the plunger comprising a seal and one or more lockingarms having a length, whereupon the locking arms being disposedproximally and exterior of the barrel, the seal is disposed within thechamber proximally of the opening, a flexible tubular member extendingfrom the distal end of the handle, the flexible tubular membercomprising a proximal end, a distal end, an inflation lumen coupled tothe plunger and extending from the proximal end of the flexible tubularmember, and a second lumen extending from the proximal end of theflexible tubular member to a port, an expandable member attached to theflexible tubular member, the expandable member comprising a proximal endand as distal end, wherein the inflation lumen opens into the expandablemember, wherein the port is disposed proximally of the proximal end ofthe expandable member, and an illumination device disposed adjacent thedistal end of the flexible tubular member and distally of the expandablemember.

The device may also or alternatively include locking arms disposed inthe chamber and adjacent a proximal orifice of the barrel while the sealis disposed within the chamber adjacent or distal the opening. Thedevice may also or alternatively include locking arms being disposed inthe chamber and distal of a proximal orifice of the barrel while theseal is disposed within the chamber distal the opening.

An alternative device in accordance with this disclosure for use inperforming a sphenopalatine ganglion block, which may involve deliveringmedication to a patient, or other type of medical procedure may includea handle comprising a proximal end and a distal end, an inflation deviceat least partially disposed within the handle, a flexible tubular memberextending from the distal end of the handle, the flexible tubular membercomprising a proximal end, a distal end, an inflation lumen coupled tothe plunger and extending from the proximal end of the flexible tubularmember, and a second lumen extending from the proximal end of theflexible tubular member to a port, an expandable member attached to theflexible tubular member, the expandable member comprising a proximal endand a distal end, wherein the inflation lumen opens into the expandablemember, an illumination device disposed adjacent the distal end of theflexible tubular member and distally of the expandable member, and astabilizer slidably coupled to the flexible tubular member, wherein thestabilizer is capable of sliding along the flexible tubular memberbetween the handle and the expandable member.

The device may also or alternatively be designed such that thestabilizer comprises a lumen, wherein the flexible tubular member isslidably disposed within the lumen, which has a proximal end and adistal end. The stabilizer may also or alternatively be compressiblesuch that it has an uncompressed state and a compressed state.Additionally, the distal end of lumen within the stabilizer may also anoval cross-sectional profile when the stabilizer is in the uncompressedstate a circular cross-sectional profile when the stabilizer is in theuncompressed state or vice versa.

The stabilizer may also or alternatively be configured such that thestabilizer is compressible. When the flexible tubular member is disposedin the lumen and the stabilizer is able to slide relative to theflexible tubular member, the stabilizer is able to slide over theflexible tubular member when the stabilizer is in a compressed state andis prevented from sliding over and relative to the flexible tubularmember when the stabilizer is in an uncompressed state. The sliding ofthe stabilizer relative to the flexible tubular member is potentiallymade possible by the size of the circumference of the lumen beinggreater than the size of the circumference of the flexible tubularmember during such sliding action, regardless of whether the stabilizeris in its compressed state or its uncompressed state, thereby insuringthat the stabilizer can slide relative to the flexible tubular member.Accordingly, the stabilizer may be prevented from sliding over theflexible tubular member when one or more portions of the lumen contactsone or more portions the flexible tubular member, which may occur whenthe stabilizer is in an uncompressed state because portions of the ovalshaped lumen contact the flexible tubular member. That is, when thestabilizer is in an uncompressed state it is unable to slide over theflexible tubular member due to the frictionally contact between thestabilizer and the flexible tubular member.

An alternative method in accordance with this disclosure for performinga sphenopalatine ganglion block, which may involve delivering medicationto a patient, or other type of medical procedure may include inserting adevice into a portion of a nasal cavity of a patient through a nostril,the device comprising a handle comprising a proximal end and a distalend, an inflation device at least partially disposed within the handle,a flexible tubular member extending from the distal end of the handle,the flexible tubular member comprising a proximal end, a distal end, aninflation lumen coupled to the plunger and extending from the proximalend of the flexible tubular member, and a second lumen extending fromthe proximal end of the flexible tubular member to a port, an expandablemember attached to the flexible tubular member, the expandable membercomprising a proximal end and a distal end, wherein the inflation lumenopens into the expandable member, wherein the port is disposedproximally of the proximal end of the expandable member, an illuminationdevice disposed adjacent the distal end of the flexible tubular memberand distally of the expandable member, and a stabilizer slidably coupledto the flexible tubular member, wherein the stabilizer is capable ofsliding along the flexible tubular member between the handle and theexpandable member, activating the illumination device, placing theexpandable member adjacent the patient's choana, expanding theexpandable member adjacent the patient's choana, sliding the stabilizeradjacent the patient's nose, introducing a medication to sphenopalatineganglion through the port in the flexible tubular member, removing atleast a portion of the medication through the port in the flexibletubular member, collapsing the expandable member sliding the stabilizerdistal the patient's nose, and removing the device from the nasalcavity.

The device used in this method may also be used again by inserting thedevice into a second portion of the nasal cavity of the patient througha second nostril and performing same steps performed on the secondnostril as those steps were performed on the first nostril.

The phrases “at least one”, “one or more”, and “and/or” are open-endedexpressions that are both conjunctive and disjunctive in operation. Forexample, each of the expressions “at least one of A, B and C”, “at leastone of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B,or C” and “A, B, and/or C” means A alone, B alone, C alone, A and Btogether, A and C together, B and C together, or A, B and C together.When each one of A, B, and C in the above expressions refers to anelement, such as X, Y, and Z, or class of elements, such as X₁-X_(n),Y₁-Y_(m), and Z₁-Z_(o), the phrase is intended to refer to a singleelement selected from X, Y, and Z, a combination of elements selectedfrom the same class (e.g., X₁ and X₂) as well as a combination ofelements selected from two or more classes (e.g., Y₁ and Z_(o)).

The term “a” or “an” entity refers to one or more of that entity. Assuch, the terms “a” (or “an”), “one or more” and “at least one” may beused interchangeably herein. It is also to be noted that the terms“comprising”, “including”, and “having” may be used interchangeably.

The term “compressed state” shall mean a state of an object upon beingsqueezed, compacted, and/or condensed or the like. And the term“uncompressed state” shall mean a state of an object when it is notsqueezed, compacted, and/or condensed or the like.

The term “means” as used herein shall be given its broadest possibleinterpretation in accordance with 35 U.S.C. Section 112(f). Accordingly,a claim incorporating the term “means” shall cover all structures,materials, or acts set forth herein, and all of the equivalents thereof.Further, the structures, materials or acts and the equivalents thereofshall include all those described in the summary of the invention, briefdescription of the drawings, detailed description, abstract, and claimsthemselves.

The term “medication” shall mean a substance used for medical treatment,such as a medicine or drug or remedy having in a specified formulation.The medicinal substance may also be referred to as a medicament. For thepurposes of this disclosure a medication shall include anesthetics,including but not limited to local anesthetics, general anestheticsand/or the combination thereof. Examples of local anesthetics include,but are not limited to the following: amylocaine; ambucaine; articaine;benzocaine; benzonatate; bupivacaine; butacaine; butanilicaine;chloroprocaine; cinchocaine; cocaine; cyclomethycaine; dibucaine;diperodon; dimethisoquin; dimethocaine (larocaine); eucaine; etidocaine;hexylcaine; hydroxyprocaine; Isobucaine; levobupivacaine; lidocaine(lignocaine); mepivacaine; meprylcaine; metabutoxycaine; orthocaine;oxetacaine (oxethazaine); oxybuprocaine (benoxinate); paraethoxycaine;phenacaine; piperocaine (metycaine); piridocaine; pramocaine(pramoxine); prilocaine; primacaine; procaine; procainamide;proparacaine (proxymetacaine); propoxycaine; pyrrocaine; quinisocaine(dimethisoquin); ropivacaine; trimecaine; tetracaine (amethocaine);tolycaine; and tropacocaine. Examples of other drugs may includeneurotoxins, such as botulinum toxin, including botulinum toxin type A,which may include onabotulinumtoxinA, abobotulinumtoxinA, andincobotulinumtoxinA, and botulinum toxin type B, which may includerimabotulinumtoxinB.

The term “transillumination” shall mean the transmission of lightthrough body tissue, such as the palate (including both the soft palateand hard palate).

It should be understood that every maximum numerical limitation giventhroughout this disclosure is deemed to include each and every lowernumerical limitation as an alternative, as if such lower numericallimitations were expressly written herein. Every minimum numericallimitation given throughout this disclosure is deemed to include eachand every higher numerical limitation as an alternative, as if suchhigher numerical limitations were expressly written herein. Everynumerical range given throughout this disclosure is deemed to includeeach and every narrower numerical range that falls within such broadernumerical range, as if such narrower numerical ranges were all expresslywritten herein.

The preceding is a simplified summary of the disclosure to provide anunderstanding of some aspects of the disclosure. This summary is neitheran extensive nor exhaustive overview of the disclosure and its variousaspects, embodiments, and configurations. It is intended neither toidentify key or critical elements of the disclosure nor to delineate thescope of the disclosure but to present selected concepts of thedisclosure in a simplified form as an introduction to the more detaileddescription presented below. As will be appreciated, other aspects,embodiments, and configurations of the disclosure are possibleutilizing, alone or in combination, one or more of the features setforth above or described in detail below

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are incorporated into and form a part of thespecification to illustrate several examples of the present disclosure.These drawings, together with the description, explain the principles ofthe disclosure. The drawings simply illustrate preferred and alternativeexamples of how the disclosure may be made and used and are not to beconstrued as limiting the disclosure to only the illustrated anddescribed examples. Further features and advantages will become apparentfrom the following, more detailed, description of the various aspects,embodiments, and configurations of the disclosure, as illustrated by thedrawings referenced below.

FIG. 1 is a perspective view of an embodiment of a surgical device ofthe present disclosure;

FIG. 2 is an alternate perspective view of the surgical device depictedin FIG. 1;

FIG. 3 is a top view of the surgical device depicted in FIG. 1;

FIG. 4 is a side view of the surgical device depicted in FIG. 2;

FIG. 4A is an enlarged cross-sectional view of the distal end of theelongated flexible tubular member distal of the expandable member of thesurgical device depicted in FIG. 4;

FIG. 4B is a cross-sectional end view of the elongated flexible tubularmember of the surgical device depicted in FIG. 4 taken along line B-B;

FIG. 4C is a cross-sectional side view of the elongated flexible tubularmember depicted in FIG. 4B taken along line C-C;

FIG. 4D is a cross-sectional view of the handle of the surgical devicedepicted in FIG. 4;

FIG. 5A is a cross-sectional view of the plunger located within thehandle of the surgical device depicted in FIG. 4D, wherein the plungeris illustrated in an extended position;

FIG. 5B is a cross-sectional view of the plunger located within thehandle of the surgical device depicted in FIG. 4D, wherein the plungeris illustrated in a retracted position;

FIG. 5C is a cross-sectional view of the syringe depicted in FIG. 5A;

FIG. 6A is a cross-sectional view of a patient's head with an embodimentof a surgical device of the present disclosure, with the expandablemember in a deflated state, entering the patient's nasal cavity;

FIG. 6B is a cross-sectional view of a patient's head with an embodimentof a surgical device of the present disclosure, with the expandablemember in a deflated state, located in the patient's nasal cavity;

FIG. 6C is a cross-sectional view of a patient's head with an embodimentof a surgical device of the present disclosure, with the expandablemember in a deflated state, located in the patient's nasal cavity withthe expandable member disposed adjacent the choana;

FIG. 6D is a cross-sectional view of a patient's head with an embodimentof a surgical device of the present disclosure, with the expandablemember in an inflated state, located in the patient's nasal cavity withthe expandable member disposed adjacent the choana;

FIG. 6E is a cross-sectional view of a patient's head with an embodimentof a surgical device of the present disclosure, with the expandablemember in an inflated state, located in the patient's nasal cavity withthe expandable member disposed adjacent the choana and medicationaccumulated in the patient's nasal cavity adjacent the SPG;

FIG. 7 is flow chart depicting a method of performing a surgicaltechnique using a surgical device of the present disclosure;

FIG. 8A is an enlarged cross-sectional view of an alternative embodimentof the distal end of the elongated flexible tubular member distal of theexpandable member of the surgical device depicted in FIG. 4;

FIG. 8B is a cross-sectional end view of an alternative embodiment ofthe elongated flexible tubular member of the surgical device depicted inFIG. 4 taken along line B-B;

FIG. 8C is a cross-sectional side view of the elongated flexible tubularmember depicted in FIG. 8B taken along line C-C;

FIG. 9A is a cross-sectional side view of an alternative embodiment ofthe elongated flexible tubular member depicted in FIG. 8C with theexpandable member depicted in the expandable state;

FIG. 9B is a cross-sectional side view of another alternative embodimentof the elongated flexible tubular member depicted in FIG. 8C with theexpandable member depicted in the expandable state;

FIG. 10A is a top view of an alternative embodiment of the surgicaldevice depicted in FIGS. 1-4;

FIG. 10B is a top view of another alternative embodiment of the surgicaldevice depicted in FIGS. 1-4;

FIG. 11A is a cross-sectional view of a patient's head with anembodiment of a surgical device of FIG. 10A located in the patient'snasal cavity with the expandable member disposed adjacent the choana andmedication accumulated in the patient's nasal cavity adjacent the SPGand a second expandable member disposed adjacent and exterior of thepatient's nostril;

FIG. 11B is a cross-sectional view of a patient's head with anembodiment of a surgical device of FIG. 10B located in the patient'snasal cavity with the expandable member disposed adjacent the choana andthe delivery device in the patient's nasal cavity adjacent the SPG, anda second expandable member disposed adjacent and exterior of thepatient's nostril;

FIG. 12 is flow chart depicting an alternative method of performing asurgical technique using an alternative embodiment of the surgicaldevice of the present disclosure;

FIG. 13 is a cross-sectional view of an alternative embodiment of thesyringe illustrated in a retracted position during shipment;

FIG. 13A is an enlarged a cross-sectional view of the embodiment of thesyringe of FIG. 13, wherein the plunger is illustrated in a retractedposition during shipment; in an extended position;

FIG. 14 is a cross-sectional view of an alternative embodiment of thesyringe illustrated in an initially retracted position during shipmentand/or prior to use;

FIG. 14A is an enlarged a cross-sectional view of an alternativeembodiment of the syringe of FIG. 14, wherein the plunger is illustratedin an initially retracted during shipment and/or prior to use;

FIG. 15 is a cross-sectional view of an alternative embodiment of theplunger illustrated in an extended position;

FIG. 16 is a side view of the plunger of the alternative embodiment ofthe syringe depicted in FIG. 13;

FIG. 16A is a cross-sectional view of the plunger in FIG. 16, whereinthe locking arms, particularly the distal ends of the locking arms, arein a fully radially outward extended position relative to the shaftportion of the plunger;

FIG. 16B is a cross-sectional view of the plunger in FIG. 16, whereinthe locking arms, particularly the distal ends of the locking arms, arein a fully radially inward position relative to the shaft portion of theplunger;

FIG. 16C is a cross-sectional view of the plunger in FIG. 16, whereinthe locking arms, particularly the distal ends of the locking arms, arein a partially radially outward extended position relative to the shaftportion of the plunger;

FIG. 17 is a side view of an alternative embodiment of the surgicaldevice depicted in FIG. 4;

FIG. 18 is a cross-sectional view of the alternative embodiment of thehandle of the surgical device depicted in FIG. 17;

FIG. 19A is an illustration of a schematic of a circuit wherein a pulltab is interrupting both paths of the circuit;

FIG. 19B is an illustration of a schematic of a circuit wherein the pulltab in FIG. 19A is omitted and therefore not interrupting the circuit,which includes one closes path and one open path;

FIG. 19C is an illustration of a schematic of a circuit wherein the pulltab in FIG. 19A is omitted and therefore not interrupting the circuit,which includes two closed paths;

FIG. 20A is a perspective view of an alternative embodiment of asurgical device of the present disclosure, wherein the stabilizer isdisposed proximate the handle of the surgical device;

FIG. 20B is a perspective view of the alternative embodiment of thesurgical device illustrated in FIG. 20A, wherein the stabilizer isdisposed distally of the handle of the surgical device;

FIG. 21A is a cross-sectional view of a patient's head and theembodiment of the surgical device illustrated in FIG. 20A, wherein theexpandable member is in an inflated state and located in the patient'snasal cavity and disposed adjacent the choana, wherein the stabilizer isdisposed distally of the patient's nose;

FIG. 21B is a cross-sectional view of a patient's head and theembodiment of the surgical device illustrated in FIG. 20A, wherein theexpandable member is in an inflated state and located in the patient'snasal cavity and disposed adjacent the choana, wherein the stabilizer isdisposed adjacent and/or contacts the patient's nose;

FIG. 22A is an enlarged perspective view of the stabilizer and elongatedflexible tubular member illustrated in FIGS. 20A and 20B;

FIG. 22B is a cross-sectional end view of the stabilizer and elongatedflexible tubular member depicted in FIG. 22A taken along line A-A,wherein the stabilizer is in an uncompressed state;

FIG. 22C is an alternative embodiment of the cross-sectional end view ofthe stabilizer and elongated flexible tubular member depicted in FIG.22A taken along line A-A, wherein the stabilizer is in a compressedstate;

FIG. 22D is a cross-sectional end view of the stabilizer and elongatedflexible tubular member depicted in FIG. 22A taken along line B-B; and

FIG. 23 is flow chart depicting an alternative method of performing asurgical technique using an alternative embodiment of the surgicaldevice of the present disclosure, particularly the alternativeembodiment of the surgical device depicted in FIGS. 20A and 20B.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary for anunderstanding of the disclosure or that render other details difficultto perceive may have been omitted. It should be understood, of course,that the disclosure is not necessarily limited to the particularembodiments illustrated herein.

DETAILED DESCRIPTION

Before any embodiments of the disclosure are explained in detail, it isto be understood that the disclosure is not limited in its applicationto the details of construction and the arrangement of components setforth in the following description or illustrated in the followingdrawings. The disclosure is capable of other embodiments and of beingpracticed or of being carried out in various ways. Also, it is to beunderstood that the phraseology and terminology used herein is for thepurpose of description and should not be regarded as limiting. The useof “including,” “comprising,” or “having” and variations thereof hereinis meant to encompass the items listed thereafter and equivalentsthereof as well as additional items.

Embodiments according to this disclosure provide a surgical device thatcan be deployed safely within a nasal cavity of a patient and apply amedication, such as a local anesthetic, to the patient's sphenopalatineganglion. FIG. 1-FIG. 4 depict a surgical device 100 having a handle 104and an elongated flexible tubular member 108. The handle 104, which isergonomically shaped, includes a proximal end and a distal end 144. Theproximal end of the handle includes two projecting abutments 136, 140 sothat the user's hand remains comfortably on the handle 104 during useand the user's hand does not slide off the handle 104. It may bepreferable for the projecting abutments 136, 140 to be disposed on thetop and bottom of the handle such that they are about 180 degreesopposed from one another, as illustrated in the FIGS. 1 & 2, or it maybe preferable for the projecting abutments 136, 140 to be disposed in adifferent orientation with respect to the handle, such as on the sidesof the handle 104. It may also be preferable to have less or more thantwo abutments. For example, it may be preferable to have a continuousabutment around the entire circumference of the handle 104 at or nearits proximal end. As will be discussed in more detail below, whenoperating the handgrip or finger grip, such as a ring 158, theprojecting abutments 136, 140 allow the clinician to ergonomically andcomfortably depress and retract the barrel 172. For example, theclinician may insert his thumb in the ring 158 and locate his fingers onthe distal side of the projecting abutments 136, 140 and depress thebarrel 172 with one hand.

As illustrated in FIG. 4, the handle 104 is curved. The proximal portionof the handle 104 has one longitudinal axis and the distal portion ofthe handle 104 has a different longitudinal axis. The longitudinal axisof the distal portion of the handle 104 may be offset at an angle ofabout 5 degrees about 60 degrees from the longitudinal axis of theproximal portion of the handle 104. It may be preferable for the offsetangle to be about 10 degrees about 45 degrees and even more preferablefor the offset angle to be about 20 degrees to about 30 degrees. Thelongitudinal axes of the proximal and distal portions of the handle 104smoothly intersect, thereby creating a handle with a curved profile. Thedistal end 144 of the of the handle portion 104 may also have a roundedconfiguration, which is more ergonomic to engage the patient'snostril(s) upon insertion of the device 100, namely the elongatedflexible tubular member 108, thereto.

The elongated flexible tubular member 108 includes a proximal end 120,which is attached to the distal end of the 144 of the handle 104. Anexpandable member 116, such as a balloon, is located at, adjacent to ortoward the distal end 124 of the flexible tubular member 108. FIGS. 1 &3 depict the expandable member 116 in an inflated state, and FIGS. 2 & 4depict the expandable member 116 in a deflated state. The shape and sizeof the expandable member 116 may differ depending upon the patient'sanatomy. For example, the size of the expandable member 116 may besmaller for children and larger for adults. It may be preferable for theexpandable member 116 to have an inflated diameter of about 1 cm to 4cm, with a possible preferential diameter of about 2.5 cm, and aninflated length of about 1 cm to 3, with a possible preferentialinflated length of about 2.5 cm.

As discussed in more detail below, the handle 104 includes an inflationdevice, such as a syringe 112, integrated therein. The syringe 112comprises a barrel 172, a plunger 164 at least partially disposed withinthe barrel 172, and a distal tip 176 at the end of the barrel 172. Whenthe plunger 164 is depressed, the expandable member 116 is expanded(inflated) with fluid, such as air, and when the plunger 164 isrefracted, the expandable member 116 is collapsed (deflated). It shallbe understood that either a pneumatic inflation device, which utilizesair as the fluid, or a hydraulic inflation device, which utilizes liquid(e.g., saline, water, etc.) as the fluid, can be used.

The handle 104 also includes a switch 128 for activating an illuminationdevice 216, such as a light-emitting diode (LED) disposed at or towardthe distal end 124 of the elongated flexible tubular member 108. Theswitch 216 activates a power source, such as a battery, that is coupledto the illumination device 216 by two or more conductors (e.g., wires)224, 228. The wires 224, 228 are disposed within lumens 224, 228 thattravel from the proximal end to the distal end of the elongated flexibletubular member 108. As discussed above, the expandable member 116 isalso disposed at or near or toward the distal end 124 of the elongatedflexible tubular member 108. It is preferable for the illuminationdevice 216 to be disposed distally of the expandable member 116 alongthe elongated flexible tubular member 108, thereby allowing theillumination device 216 to project light in a manner that isunobstructed by the expandable member 116. That is, it is preferable forthe expandable member 116 to be disposed proximally of the illuminationdevice 216 along the elongated flexible tubular member 108. For example,it may be preferable for the distal end of the expandable member 116 tobe disposed about 0 to 1 mm and potentially even more preferable to bedisposed at the distal end 124 of the elongated flexible tubular member108.

An alternative illumination device 216 may include an illumination fiber(not shown) that is attached to and/or integral with the elongatedflexible tubular member 108 such that the illumination fiber is exposedat the same location that the LED would have been disposed—at or towardthe distal end 124 of the elongated flexible tubular member 108. Theproximal end of the illumination is coupled to a light source that canbe disposed interiorly and/or exteriorly of the handle 104. The lightsource can be powered by a direct current power source or an alternatingcurrent power source.

Referring to FIG. 4, there is depicted a side view of an embodiment ofthe surgical device 100 of the present disclosure. FIG. 4A is anenlarged cross-sectional view of the distal end 124 of the elongatedflexible tubular member 108 illustrating a portion of the expandablemember 116 in a deflated state. The distal end 124 of the elongatedflexible tubular member 108 includes a cover 220 coupled to it. Thecover 220 is constructed of a transparent material, such aspolycarbonate. The cover 220 protects the illumination device 216. Thecover 220 may also be shaped such that its edges are curved, therebyproviding an atraumatic end to the surgical device. The cover 220 can becoupled directly to the distal face 222 of the elongated flexibletubular member 108 and/or it can be coupled to the perimeter of thedistal end 124 of the elongated flexible tubular member 108. The tip 220may preferably be coupled to the distal end 124 of the elongatedflexible tubular member 108 by an adhesive compound. Alternative meansof coupling the tip 220 to the distal end 124 of the elongated flexibletubular member 108 includes mechanical means, such as pressed fittings,snap on fittings, or a threaded arrangement between the tip 220 and theelongated flexible tubular member 108.

Continuing to refer to FIG. 4A, there is depicted an illumination device216, which is also coupled to the distal face 222 of the elongatedflexible tubular member 108 such that the illumination device projectslight distally of the elongated flexible tubular member 108. Similar totip 220, the illumination device 216 is coupled to the distal end 124 ofthe elongated flexible tubular member 108 by an adhesive. It may also bepreferable for the tip 220 to surround at least a portion of theillumination device 216, thereby protecting the illumination device 216.The illumination device is powered by a power source, such as a battery,via one or more wires 224, 228 that couple the power source to theillumination device 216. The wires 224, 228 are disposed within lumens224, 228 that travel from the proximal end to the distal end of theelongated flexible tubular member 108.

Referring to FIG. 4B, there is depicted a cross-sectional view of theelongated flexible tubular member 108 of the surgical device 100depicted in FIG. 4 taken along line B-B. The elongated flexible tubularmember 108 comprises a plurality of lumens. Although a different numberof lumens may be used, FIG. 4B illustrates four lumens: lumen 148 isused to transport the medication to/from the medication port 160 locatedproximally of the expandable member 116; lumen 200 is used to transportfluid (e.g., air, water, saline, etc.) to/from the inflation port, whichopen into the expandable member 116; and two lumens 204, 208 providechannels for the wires 224, 228 to travel. All four lumens 148, 200, 204& 208 have openings at the proximal end of the elongated flexibletubular member 108. Not all four lumens, however, may have openings atthe distal end of the elongated flexible tubular member 108. Forexample, the lumen 148 used to transport the medication may have anopening at the proximal end of the elongated flexible tubular member 108and an opening (or port) at 160 through the wall of the tubular member108, which is located proximally of the expandable member 116.Additionally, the lumen 200 used to transport fluid to inflate theexpandable member 116 may have a have an opening at the proximal end ofthe elongated flexible tubular member 108 and an opening (or port) at212, which opens into the expandable member 116. Lumens 204, 208 mayhave an opening at the proximal end of the elongated flexible tubularmember 108 and an opening at or near the distal end of the elongatedflexible tubular member 108, thereby allowing the wires 224, 228 totravel all or the majority of the length of the elongated flexibletubular member 108 to the illumination device 216.

Alternatively, the elongated flexible tubular member 108 may not havelumens 204, 208. For example, if the elongated flexible tubular member108 is constructed (e.g., molded) in a manner such that the wires 224,228 are integral with the elongated flexible tubular member 108, thenlumens 204, 208 may not be needed. Additionally, the elongated flexibletubular member 108 may have additional lumens 206, 210.

Another alternative embodiment may include an additional lumen in theelongated flexible tubular member 108 through which an imaging devicemay be inserted or incorporated. For instance, the surgical device 100may include a reusable endoscope that is inserted through an opening(not shown) in the handle 104 and travels through the additional lumenin the elongated flexible tubular member 108 such that the endoscope isadjacent the illumination device 216 in the cover 220. Referring toFIGS. 8A, 8B & 8C, there is depicted such an alternative embodiment ofthe flexible tubular member 108′ that includes lumen 202′, which extendsfrom the proximal end to the distal end of the flexible tubular member108′, and is configured to have an endoscope or other imaging deviceinserted thereto. Lumen 148′ will be used to transport the medicationto/from the medication port 160′ located proximally of the expandablemember 116; two lumens 204, 208 provide channels for the wires 224, 228to travel to/from the illumination device 220; lumen 206′ is used totransport fluid (e.g., air, water, saline, etc.) to/from the inflationport, which open into the expandable member 116; and lumen 208′ is anadditional lumen. Although it is not shown in the figures, it may alsobe desirable for the cover and/or the distal end of the flexible tubularmember to have an optical divider that separates the light emitted bythe illumination device from directly entering the endoscope or imagingdevice.

Regarding the placement of the opening 160 through the wall of thetubular member 108 for delivering the medication, it may be preferablefor the opening 160 to be disposed about 1 mm to 10 mm from the proximalend of the expandable member 116 and possibly more preferably to bedisposed about 2 mm to 5 mm from the proximal end of the expandablemember 116. Locating the opening 160 through the wall of the tubularmember 108 proximally of the proximal end of the expandable member 116allows the medication to collect within the nasal cavity above theexpandable member 116, while the expandable member 116 is inflated. Itmay be preferable for the medication to collect within the nasal cavityand form a pool of medication such that the level of medication rises tosphenopalatine fossa and/or the mucosa overlaying the SPG. Dependingupon the size of the patient's nasal cavity, the volume of medicationintroduced to the nasal cavity and used to create such a pool may bebetween 2 milliliters to 15 milliliters, and potentially preferable forabout 5 milliliters to 10 milliliters.

Referring to FIG. 4D, FIG. 5A. FIG. 5B and FIG. 5C, an inflation device,such as a syringe 112, is integrated into the handle 104. The syringe112 is used to inflate and deflate the expandable member 116.Integrating the inflation device in the handle 104 reduces thelikelihood of a clinician confusing which port(s) to connect the devices(i.e., syringes) used to introduce the medication and the inflationfluid. That is, by including an inflation device, such as the syringe112, in the handle 104, a clinician will know and/or be instructed touse the integrated syringe 112 to inflate the expandable member 116 andan external syringe (not shown) to introduce the medication. Stateddifferently, a clinician will only have to introduce one fluid, namelythe medication, through an external syringe, thereby reducing potentialconfusion as to which fluid to introduce and/or into which port.Alternatively, the syringe used to introduce the medication may beintegrated into the handle 104 in lieu of the syringe 112 used toinflate and deflate the expandable member 116. A further alternativeembodiment may include a handle 104 with two clearly marked integratedsyringes—one syringe for the medication and another syringe for theinflation fluid.

The syringe 112 comprises a barrel 172, a plunger 164 at least partiallydisposed within the barrel 172, and a distal tip 176 having an openingat the distal end of the barrel 172. The plunger 164 has a shaft portion166 and a proximal end 162 and distal end 168 at the respective ends ofthe shaft portion 166. A cross section of the shaft portion 166 isillustrated in FIG. 5C, which depicts the shaft portion 166 as having an“X” or “T” cross sectional profile. This cross sectional profilepotentially increases the strength and rigidity of the shaft portion166. The proximal end 162 and a distal end 168 may be coupled to theshaft portion 166 or be integrally formed thereto. The proximal portion162 may also have a handgrip or finger grip, such as a ring 158, for aclinician to ergonomically and comfortably depress and retract thebarrel 172. When the plunger 164 is depressed, the expandable member 116is inflated, and when the plunger 164 is retracted, the expandablemember 116 is deflated.

It may also be preferable for the barrel 172 to have an opening (port)170 through the wall of the tubular member 108 adjacent, at or towardits proximal end. When the surgical device 100 is manufactured, it isassembled and/or packaged at a certain atmospheric pressure dependingupon the geographic location of the manufacturing and/or packagingfacility. The atmospheric pressure of the surgical site where thesurgical device 100 is used, however, may be different than that at themanufacturing and/or packaging facility. Including the opening 170through the wall of the barrel 172 allows the pressure within barrel toequalize with the pressure of the surgical site prior to use. It mayalso be preferable to ship the surgical device 100 in a configurationsuch that the plunger 164 is in a partially or fully retracted positionsuch, thereby allowing the opening 170 to be located distally of thedistal end 168 of the plunger 164. Shipping the surgical device in thisconfiguration may enhance the time for the pressure within the chamberof the barrel to equalize with the atmospheric pressure at the surgicalsite more quickly.

During use of the surgical device 100, clinicians may also repeatedlydepress and retract the plunger 164. Such repeated action has thepotential to overinflate the expandable member 116. Inclusion of theopening 170 through the wall of the barrel 172 allows the pressurewithin barrel's chamber 174 to equalize with the atmospheric pressureupon retraction of the plunger 164, thereby reducing the likelihood ofoverinflating the expandable member 116. That is, upon depression of theplunger 164, the pressure within the chamber 174, as well as thepressure within the expandable member 116, increases above atmosphericpressure at the surgical site. Upon each retraction of the plunger 164,the pressure within the chamber 174, as well as the pressure within theexpandable member 116, decreases back to atmospheric pressure prior toanother depression of the plunger 164 because the fluid within thechamber 174 is vented to the atmosphere via the opening 170.

Venting the fluid within the chamber 174 also allows the expandablemember 116 to deflate (or further deflate) upon application of pressureto the exterior of the expandable member 116. For example, uponretraction of the plunger 164, the pressure within the expandable member116 may not immediately cause the expandable member 116 to completelydeflate. That is, the expandable member 116 may retain a certain amountof fluid after retraction of the plunger, thereby allowing theexpandable member 116 to remain partially inflated. Accordingly, whenthe surgical device 100, including the expandable member 116, isinitially removed from the patient's nasal cavity, the expandable member116 may be partially inflated. Inclusion of opening 170 within chamber174 allows the expandable member 116 to further deflate upon removal ofthe surgical device 100, including the expandable member 116, from thepatient's nasal cavity. Allowing the expandable member 116 to furtherdeflate upon removal of the surgical device 100 assists in reducing thelikelihood of the expandable member 116 causing discomfort to thepatient.

Continuing to refer to FIG. 4D, a pressure relief valve 188 is disposedbetween the syringe 112 and the expandable member 116. Inclusion of thepressure relief valve 188 into the inflation circuit reduces thepossibility of over pressurizing and over expanding the expandablemember 116, particularly during a clinician's repeated depression andretraction of the plunger 164. The pressure relief valve 188 is a valveused to control or limit the pressure in a circuit, such as theinflation circuit. The pressure is relieved by allowing the pressurizedfluid (e.g., air) to flow to an auxiliary passage, preferably in thevalve, out of the circuit. The pressure relief valve is designed or setto open at a predetermined set pressure to protect the expandable member116 from being subjected to pressures that exceed the desired clinicallimits. When the set pressure is exceeded, the pressure relief valve isforced open and a portion of the fluid is diverted through the auxiliaryroute vented to the atmosphere. As the fluid is diverted, the pressureinside the circuit decreases. Once the pressure within the pressurerelief valve reduces back to or below the predetermined set pressure,the valve will close. For example, the predetermined set pressure may beset between about 5 psi (0.345 bars) to 15 psi (1.034 bars) or possiblybetween about 8 psi (0.552 bars) to 12 psi (0.827 bars) or nominallyabout 10 psi (0.690 bars).

The pressure relief valve 188, particularly the proximal end of thepressure relief valve 188, is coupled to the distal tip 176 of thesyringe 112. The distal end of the pressure relief valve 188 is, inturn, coupled to the tube 192 that is coupled to the inflation lumen 148in the elongated flexible tubular member 108. Alternatively, the tube192 may be omitted by directly coupling the distal end of the pressurerelief valve 188 to the inflation lumen 148 in the elongated flexibletubular member 108.

Also disclosed herein is an alternative embodiment included within thesurgical device 100 to accommodate for the change in atmosphericconditions that may exist between the manufacturing and/or packagingfacility and the surgical site, while also reducing the likelihood ofoverinflating the expandable member 116. The embodiment of the syringe1312 depicted in FIGS. 13-15 may negate the need for the inclusion ofthe pressure relief valve 18 discussed herein above. Referring to FIGS.13 and 13A, as well as FIGS. 16, 16A, 16B and 16C, there is depicted analternative embodiment of the syringe 1312 of the present disclosure.The syringe 1312 comprises a barrel 1372, and a plunger 1364 at leastpartially inserted within the barrel 1372. The plunger 1364 has a shaftportion 1366 and a proximal end 1362 and distal end 1368 at therespective ends of the shaft portion 1366. The barrel 1372 includes adistal tip 1376 having an opening at the distal end of the barrel 1372.The proximal end 1362 and a distal end 1368 of the plunger 1364 may becoupled to the shaft portion 1366 or be integrally formed thereto. Theproximal portion 1362 may also have a handgrip or finger grip, such as aring 1358, for a clinician to ergonomically and comfortably depress andretract the barrel 1372. When the plunger 1364 is depressed, theexpandable member 116 is inflated, and when the plunger 1364 isretracted, the expandable member 116 is deflated due to the supply andremoval of fluid through the inflation lumen 148.

Continuing to refer to FIGS. 13 and 13A, as well as FIGS. 16, 16A, 16Band 16C, the proximal end of the barrel 1372 may include a flange 1374that is disposed within a flange recess 1388 of a housing 1384, which iscoupled to the handle 104. Alternatively, the handle 104 may include anintegral flange recess 1388 in which the flange 1374 may be disposed,thereby negating the need for a separate housing 1384. Regardless ofwhether the flange 1374 of the barrel 1372 is coupled to the handle 104either indirectly by being disposed within the flange recess 1388 of thehousing 1384, which is coupled to the handle 104, or directly to thehandle 104, the barrel 1372 remains positionally fixed with respect tothe handle 104 during shipment and use.

As discussed above with respect to FIGS. 5A & 5B, it may also bepreferable for barrel 1372 of the syringe 1312 in FIGS. 13 and 13A tohave an opening (port) 1370 through the wall of the barrel 1372adjacent, at or toward its proximal end. Including an unobstructedopening 1370 within the proximal end, for example, of the barrel 1372allows the pressure within the chamber of the barrel 1372 to equalizewith the pressure of its current geographical location, such as thesurgical site prior to use. It may also be preferable to ship thesurgical device 100 in a configuration such that the plunger 1364 is infully refracted position, thereby allowing the opening 1370 to belocated distally of the distal end 1368 of the plunger 1364 and,therefore, unobstructed. Shipping the surgical device in thisconfiguration allows the opening 1370 to be unobstructed by the plunger,thereby potentially decreasing the time for the pressure within thechamber of the barrel to equalize with the atmospheric pressure at thesurgical site more quickly.

Continuing to refer to FIGS. 13 and 13A, there may be a need to insurethat the distal end 1368, particularly the seal, of the plunger 1364remains proximate the opening 1370 during shipment of the surgicaldevice 100, thereby allowing the atmospheric pressure to enter into thechamber of the barrel 1372. It may be preferable, therefore, for thesyringe 1312 to include means for preventing the distal end 1368,particularly the seal, of the plunger 1364 from moving distally of theopening 1370 in the barrel 1372 during shipment. One such means mayinclude one or more locking arms 1380 coupled to the plunger 1364,wherein the locking arms 1380 have an unconstrained radially biasedposition that is greater than the orifice of the housing 1384. Referringto FIGS. 16, 16A, 16B and 16C, there is depicted four locking arms 1380attached radially symmetrically around the shaft 1366 of the plunger1364. Although four locking arms 1380 are illustrated in these figures,less than four (i.e., 1, 2 or 3) locking arms or greater than four(e.g., 5, 6, etc.) locking arms may be used. Each of the locking arms1380 have a proximal end, which are coupled to the proximal end 1362 ofplunger 1364, and a distal end 1392 extending therefrom. The lockingarms 1380 are spring biased in a radially outward direction such thatthey flare radially outwards at their distal ends 1392 in comparison totheir proximal ends.

It may also be preferable for the distal ends 1392 of the locking arms1380 to include a male tapered portion which mates with a female taperedportion 1400 of the housing 1384. During shipment and prior to usage ofthe surgical device 100, the male tapered portion of the distal ends1392 of the locking arms 1380 remains proximate the female taperedportion 1400 of the housing 1384. This is accomplished by the radiallyoutward spring bias of the locking arms 1380 which causes the distalends 1392, and particularly the male tapered portion, of the lockingarms 1380 to have a configuration outside the chamber of the barrel 1372such that the distal ends 1392 and/or the male tapered portion is biasedoutwardly to a diameter that is greater in diameter than the orifice ofthe housing, thereby causing the distal end 1392 and/or male taperedportion of the plunger 1364 to abut and contact the female taperedportion 1400 of the housing 1384. When the male tapered portion of thedistal end 1392 of the plunger 1364 abuts and contacts the femaletapered portion 1400 of the housing 1384, the seal 1368 is proximal ofthe opening 1370 within the barrel 1372. That is, the plunger 1364,particularly the shaft portion 1366 of the plunger 1364, has apredetermined length between the distal ends 1392 and/or the maletapered portions of the distal end 1392 of the locking arms 1380 and theseal 1368 such that when the surgical device is in its fully retractedposition during shipment and prior to use, the seal 1368 has a lengththat is proximal of the opening 170, thereby allowing the chamber withinthe barrel 1372 to have the same pressure as the atmosphere for thegeographic location of the surgical device. As will be discussed hereinbelow, only upon a clinician manually forcing the plunger 1364 distallywill the male tapered portion of the distal ends 1392 of the lockingarms 1380 engage the female tapered portion 1400 of the housing 1384,thereby allowing the female tapered portion 1400 and the engagement withthe male tapered portion of the distal ends 1392 of the locking arms1380 to cause the distal ends 1392 of the locking arms 1380 to moveradially inward and distally axial into orifice of the housing 1384 andthe proximal end of the lumen within the barrel 1372.

Referring to FIG. 13A, it may also be preferable for the plunger, 1364to include one or more cross sectional members 1404 having acircumference greater than a portion of lumen within the barrel. Suchportion may have a reduced diameter at a ledge or ramp 1408 within theinterior of the barrel's chamber. Such cross sectional members 1404 andramp 1408 reduce the likelihood of the plunger 1364 from movingproximally out of the barrel 1372 during shipment.

Referring to FIGS. 14 and 14A, upon opening the package in which thesurgical device 100 is shipped, the plunger 1364 is in its fullyretracted position (or un-activated position). That is, during shipmentand prior to use of the surgical device 100, the plunger 1364 is in itsfully retracted position (or un-activated position). In order to preparethe surgical device 100 for use, the clinician may manually force theplunger 1364 axially in a distal direction such that the male taperedportion of the distal ends 1392 of the locking arms 1380 move radiallyinward upon contacting the female tapered portion 1400 of the housing1384 and into the orifice of the housing 1384. After the male taperedportions of the distal ends 1392 of the locking arms 1380 move past theorifice of the housing 1384 and into the lumen of the barrel 1372, theresiliency of the locking arms 1380 forces the distal end 1392 of thelocking arms 1380 to move radially outward. And because the lumen orchamber at the proximal end of the barrel 1372 is larger than theorifice of the housing 1384, the distal ends 1392 of the locking arms1380 are allowed to move radially outward after moving axially past theorifice of the housing 1384 and into the chamber of the barrel 1372. Thedistal ends 1392 of the locking arms 1380 are flanged in comparison toat least a portion of the locking arms 1380 proximal thereto, therebyallowing the flanged portions of the distal ends 1392 of the lockingarms 1380 to be adjacent and/or abut the interior of the ridge 1396 atthe orifice of the housing 1384. Once the flanged portions of the distalends 1392 and/or the of the locking arms 1380 move axially past theorifice of the housing 1384 and into the chamber of the barrel 1372, theplunger cannot be removed from the barrel, and the surgical device is inits initial partially retracted position (or activated position) andready for use. When the surgical device is in its initial partiallyretracted position (or activated position) atmospheric pressure isprevented from entering into the chamber of the barrel 1372.

The length of the plunger 1364 is also designed such that, upon thedistal end 1392 (including the flanged portion and male taperedportions) of the locking arms 1380 springing radially outward uponintroduction into the lumen of the barrel 1372, the seal at the distalend 1368 of the plunger 1364 is disposed at or distally of the opening170 in the barrel 1372. That is, the plunger 1364, particularly theshaft portion 1366 of the plunger 1364, has a predetermined lengthbetween the distal ends 1392 of the locking arms 1380 and the seal 1368such that once the surgical device is in its initial partially retractedposition and ready for use, the seal 1368 aligns with or is distal ofthe opening 170, thereby sealing the barrel's chamber. Sealing theopening 170 ensures that no additional fluid will enter the chamber andthe initial pressure within the lumen of the barrel 1372 will be equalto that of the atmospheric pressure for the geographic location of thesurgical device immediately after sealing.

Referring to FIG. 15, after the flanged portion of the distal end 1392of the locking arms 1380 enters the housing 1384 and/or the barrel 1372,the clinician can push the plunger 1364 towards the distal end 1376 ofthe barrel 1372. When the plunger 1364 moves towards the distal end 1376of the barrel 1372, the seal 1368 moves distally of the opening 1370,thereby increasing the fluid pressure within the barrel's chamber,inflation lumen, and expandable member 116, which is then inflated. Thatis, the plunger 1364, particularly the shaft portion 1366 of the plunger1364, has a predetermined length between the distal ends 1392 of thelocking arms and the seal 1368 such that once the surgical device movesin a axially distal direction from its partially retracted position, theseal 1368 is distal of the opening 170 within the barrel 1372, therebycontinuing to seal the barrel's chamber. After the clinician pushes andextends the plunger distally, the clinician can then pull or retract theplunger 1364 such that it moves proximally. Due to the locking arms 1380being in their sprung radially outward position, the clinician can onlypull the plunger proximally to a position wherein the locking arms 1380abut and/or are adjacent the interior of the ridge 1396 at the distalend of the orifice of the housing 1384, as illustrated in FIGS. 14 and14A. Accordingly, the locking arms 1380 not only serve as a forpreventing the distal end 1368, particularly the seal, of the plunger1364 from moving distally of the opening 1370 in the barrel 1372 duringshipment, but the locking arms 1380 also serve as a means formaintaining a sealed chamber during use of the surgical device.

During use of the surgical device 100, clinicians may repeatedly depressand retract the plunger 1364. Inclusion of the opening 1370 through thewall of the barrel 1372 allows the pressure within barrel's chamber 1374reduces the likelihood of overinflating the expandable member 116because prior to its use, the chamber 1374 is at atmospheric pressurefor the geographical position at which the surgical device will be used.That is, upon depression of the plunger 1364, the pressure within thechamber 1374, as well as the pressure within the expandable member 116,increases above atmospheric pressure at the surgical site. Upon eachretraction of the plunger 1364, the pressure within the chamber 1374, aswell as the pressure within the expandable member 116, decreases back toatmospheric pressure prior to another depression of the plunger 1364because no additional the fluid will enter the chamber 174 uponretraction.

When the plunger 1364 is in a position within the barrel 1372 such thatthe male tapered portions of the distal ends 1392 of the locking arms1380 are proximal and/or abuts the female tapered portion 1400 of thehousing 1384, as illustrated in FIGS. 13 and 13A, the plunger 1364 is inits initial fully retracted position, which may be the desirableposition for shipment and prior to use. When the plunger 1364 is in itsinitial fully retracted position, the locking arms 1380, particularlythe distal ends 1392 of the locking arms 1380, are in a fully radiallyoutward extended position relative to the shaft 1366 portion of theplunger, such that the distal ends 1392 do not contact the shaft 1366,as depicted in FIG. 16A. In this initial fully retracted position, theradial exterior of the distal ends 1392 of the locking arms 1380 aresituated outward relative to the exterior of the shaft portion 1366. Asthe distal ends of the locking arms 1380 move into and through theorifice of the housing 1384, the exterior of the distal ends 1392 of thelocking arms 1380 and the exterior of the shaft portion 1366 have thesame radial position relative to one another. However, it may bepreferable for the exterior of the shaft 1366 to be situated radiallyoutward in comparison to the distal ends 1392 of the locking arms 1380,as depicted in FIG. 16B, as the locking arms 1380 pass through theorifice of the housing 1384 in order to maintain the rotational positionof the plunger 1364 with respect to the housing 1384 and/or the barrel1372. FIG. 16B illustrates the distal ends 1392 of the locking arms 1380contacting the shaft 1366.

When the plunger 1364 is in a position within the barrel 1372 such thatthe flanged portions and/or the male tapered portions of the lockingarms 1380 are distal the female tapered portion 1400 of the housing 1384and into the housing 1364 such as the flange of the distal end 1392 ofthe locking arms 1380 abuts and/or is adjacent the interior of the ridgeat the orifice of the housing 1384, as illustrated in FIGS. 14 and 14A,or distal thereto, the plunger 1364 is in its partially retractedposition and ready for use. When the plunger 1364 is in a positionwithin the barrel 1372 such that the flanged portions and/or maletapered portions of the locking arms 1380 are distal the female taperedportion 1400 of the housing 1384 and into the housing 1364 such that theflange of the distal end 1392 of the locking arms 1380 is distal theinterior of the ridge 1396 at the orifice of the housing 1384, asillustrated in FIG. 15, the plunger 1364 is in an extended position.Also, when the plunger 1364 is in a partially retracted position (asdepicted in FIGS. 14 and 14A) and/or in an extended position (asdepicted in FIG. 15), the locking arms 1380, particularly the distalends 1392 of the locking arms 1380, are in a radially outward extendedposition relative to the shaft portion 1366 of the plunger 1364, asdepicted in FIG. 16C. FIG. 16C illustrates the distal ends 1392 of thelocking arms 1380 being spaced apart from and not contacting the shaft1366 but having less space between the distal ends 1392 and the shaft1366 in comparison to FIG. 16A.

Referring again to FIG. 4D, this figure also illustrates a female lueradaptor 132 attached to the surgical device 100. The female luer adaptor132 allows a clinician to connect an auxiliary syringe (not shown)having a male luer the mates with the female luer adaptor 132. Theauxiliary syringe will include the medication that is introduced throughthe surgical device 100 proximal of the expandable member to the mucosaoverlaying the SPG. Upon actuation (e.g., depression) of the auxiliarysyringe, the medication travels from the auxiliary syringe to the femaleluer adaptor 132 through a tube 184 to the medication lumen 200 andeventually to opening 160. Alternatively, the tube 184 may be omitted bydirectly coupling the female luer adaptor 132 to the medication lumen200. An additional alternative to the present disclosure includes usinga separate tube for delivering the medication in lieu of the medicationlumen 200 within the elongated flexible tubular member 108. The separatetube could be attached or unattached to the elongated flexible tubularmember 108. The separate tube would have a proximal end, which could becoupled to the auxiliary syringe, and a distal end that includes anopening for delivering the medication.

Regardless of whether a tube 184 is included, the medication ispreferably introduced through the surgical device 100 after theexpandable member 116 is expanded because expanding the expandablemember 116 reduces the likelihood of the medication from flowing downthe patient's throat. As discussed above, after the medication isintroduced into the nasal cavity through opening 160, the medicationcollects within the nasal cavity above the expandable member, when theexpandable member 116 is expanded adjacent the choana. It may bepreferable for the medication to collect within the nasal cavity andform a pool of medication such that the level of medication rises tosphenopalatine fossa and/or the mucosa overlaying the SPG. Once thedesired medication level is attained, it may be desirable for themedication to remain in the patient's nasal cavity for a period of timeto maximize the medication's exposure to the mucosa overlaying the SPGand the SPG itself. For example, it may be desirable for the medicationto remain in the patient's nasal cavity at a level to overlay the mucosaof the SPG, for a period of time from about 5 minutes to 35 minutes,including any time interval (e.g., 1 minute, 2 minutes, 3 minutes, 4minutes, 5 minutes, etc.) there between. It may be more desirable forsuch time period to be about 10 minutes to 30 minutes, and even moredesirable for such time period to be about 15 minutes to 25 minutes, andeven further desirable for such time period to be about 20 minutes.

To assist in maintaining the preferable level of medication for thedesired time period, the auxiliary syringe may remain connected to thefemale luer adaptor 132 during such time period. After the medicationhas contacted the mucosa and the SPG for a sufficient period, theclinician may retract the auxiliary syringe, thereby removing some orall of the medication from the patient's nasal cavity through the sameopening 160 used to introduce the medication. That is, by retracting thesyringe, a negative pressure or suction force is created in themedication circuit, thereby pulling the medication located within thepatient's nasal cavity through the opening 160 and back into the same ordifferent auxiliary syringe. After the medication is withdrawn from thepatient's nasal cavity, the expandable member 116 is collapsed, and thesurgical device 100 may be removed. As discussed in more detail below,the benefit of including the expandable member 116 with the surgicaldevice 100 allows the clinician to create a blockage within thepatient's throat and fill a portion of the nasal cavity such thatmedication directly contacts the mucosa overlaying the SPG for asustained period while preventing the medication from flowing down thepatient's throat.

Referring to FIG. 7, there is depicted a flow chart 700 representing atleast some of the steps for performing a sphenopalatine ganglion blockprocedure utilizing the surgical device 100 of the present disclosure.Some of the steps of the flow chart 700 are illustrated in FIGS. 6A-6E.Step 704, which is illustrated in FIG. 6A, includes inserting thesurgical device 100 into the patient's nasal cavity through one of thepatient's nostrils (i.e., left nostril or right nostril). Specifically,the distal portion of the distal end 124 of the elongated flexibletubular member 108 is preferably inserted into the patient's nostril,while the expandable member 116 is entirely or partially deflated, anddirected into the channel below the inferior turbinate and above thehard palate. It may also be preferable at the time of insertion of thesurgical device 100 or shortly thereafter, that the illumination device216 be activated. Upon activating the illumination device 216, lightwill transmit through the patient's hard palate. For example, when thedistal end 124 of the elongated flexible tubular member 108 (and theillumination device 216) is located within the patient's nasal cavity asdepicted in FIG. 6A, the illumination device 216 will be located at orbelow the posterior inferior turbinate and above the hard palate and bevisible to a clinician viewing the interior of the oral cavity(patient's mouth), particularly the bottom of the palate (roof of thepatient's mouth), and the light will appear to be transilluminatingtherefrom within the patient's head and visible to clinician from theoral cavity.

Referring to FIG. 6B, while continuing to activate the illuminationdevice 216 and while the expandable member 116 is entirely or partiallydeflated, the distal portion of the distal end 124 of the elongatedflexible tubular member 108 is inserted further into the patient's nasalcavity. When the distal end 124 of the elongated flexible tubular member108 (and the illumination device 216) is located within the patient'snasal cavity as depicted in FIG. 6B, the illumination device 216 willcontinue to be located below the anterior of the inferior turbinateabove the anterior of the hard palate further towards the soft palate incomparison location depicted in FIG. 6A.

Referring to FIG. 6C, while continuing to activate the illuminationdevice 216 and while the expandable member 116 is entirely or partiallydeflated, the distal portion of the distal end 124 of the elongatedflexible tubular member 108 is even inserted further into the patient'snasal cavity. When the distal end 124 of the elongated flexible tubularmember 108 is located within the patient's nasal cavity as depicted inFIG. 6C, the illumination device 216 will be located above the softpalate, namely the nasopharynx, and the light will appear to betransilluminating therefrom and visible to clinician from the oralcavity. At this point, step 704 of FIG. 7 has been completed because theexpandable member 116 is located at the desired position, namely in thenasopharynx adjacent the choana.

It may also be preferable to include depth markers printed on theelongated flexible tubular member 108, wherein the depth markersindicate to the clinician the distance from the expandable member 116 tothe corresponding depth marker. For example, it may be preferable forthe elongated flexible tubular member 108 to include depth markers every1 centimeter, every 5 centimeters, every 10 centimeters from theproximal, mid- or distal portion of the balloon (or from the distal endof the flexible tubular member 108) to the corresponding depth marker.Adding such depth markers may provide the clinician with an additionalor alternative means of determining whether the expandable member 116and/or the distal end of the flexible tubular member 108 is located atthe desired position, namely in the nasopharynx adjacent the choana.

Referring to FIG. 6D, when the illumination device 216 and theexpandable member 116 are located in the nasopharynx adjacent thechoana, the expandable member 116 is expanded by depressing plunger 164of the syringe 112, as depicted in step 712 of FIG. 7, thereby blockingthe choana. Once the choana is blocked, medication is introduced to thenasal cavity through the opening 160 of the flexible tubular member 108.As the medication is introduced, the expanded expandable member 116prevents the flow of medication down the patient's throat. And becausethe patient's head it typically tilted backwards during this procedure,the medication collects proximally above the expandable member 116.Accordingly, the medication begins to accumulate within the nasalcavity. Upon a certain volume, such as 5 milliliters to 10 millilitersof medication being introduced to the nasal cavity through the opening160, the level of medication rises within the nasal cavity, namely thesphenopalatine fossa, such that the medication contacts the mucosaoverlaying the SPG. Introducing the medication in this fashion andmaintaining the desired level of medication provides for direct andsustained contact with the mucosa overlaying the SPG. The medication isabsorbed by the permeable mucosa overlying the SPG. In comparison tospraying the mucosa with the medication, the device(s) and method(s) ofthe present disclosure provide direct and sustained contact with themucosa and SPG, which is a more effective treatment. Also, varying themedication and contact times may further increase the effectiveness ofthe treatment. Varying the medication and contact times also provide theclinician the flexibility to personalize the patient's treatment.Another example of the way in which the clinician may utilize thedevice(s) and method(s) of the present disclosure to personalize thepatient's treatment includes inflating the inflatable member to acertain pressure.

As mentioned above, it may be preferable for the patient's head to betilted backwards during the procedure. Referring to FIG. 6E, it may bepreferable for the patient's head to be tilted at an angle (α) between 0degrees and 90 degrees, and more preferable for the patient's head to betilted at an angle (α) between 15 degrees and 75 degrees, and furtherpreferable for the patient's head to be tilted at an angle (a) between30 degrees and 60 degrees, and even further preferable for the patient'shead to be tilted at an angle (α) of about 45 degrees. Tilting thepatient's head during the procedure allows the medication 602 to collectabove the inflatable member 116 and contact the mucosa overlaying theSPG.

It may also be desirable to prevent the medication from being introducedor sprayed into the nasal cavity in an unknown direction. That is, itmay be desirable to control the introduction of the medication into thenasal cavity such that the medication collects within the nasal cavityabove the expandable member, forms a pool of medication 602, and thelevel of medication raises to sphenopalatine fossa and/or the mucosaoverlaying the SPG without randomly spraying the medication into thenasal cavity. Controlling the introduction of the medication in thismanner increases the likelihood that that medication reaches the mucosaoverlaying the SPG and the SPG itself. That is, upon exiting theflexible tubular member, the medication initially contacts theexpandable member and forms a pool thereof prior to contacting anytissue within the nasal cavity.

Referring to FIG. 9A and FIG. 9B, there are depicted means forcontrolling the direction from which the medication exits the flexibletubular member 108′ and is introduced to the nasal cavity. Referringspecifically to FIG. 9A, such means may include a deflector 902 thatdirects the flow of medication exiting the flexible tubular member 108′toward the expandable member 116. Directing the flow of medicationtoward the expandable member 116 reduces the likelihood that themedication will be distributed, via spraying, in an unknown direction.As illustrated in FIG. 9A, the deflector 902 is coupled to the flexibletubular member 108. The deflector 902 can be located exteriorly of theflexible tubular member 108, such as in the form of a sleeve thatsurrounds the opening 160, thereby forcing the outflow of medicationtowards the inflatable member 116. The deflector 902 can also beintegral with the flexible tubular member 108′, such that the portion ofthe flexible tubular member 108′ adjacent the opening 160 directs theoutflow of medication towards the inflatable member 116. The deflector902 may also be a separate component that is inserted at least partiallywithin the flexible tubular member 108′ and directs the outflow ofmedication towards the inflatable member 116. Alternatively, in lieu ofa deflector 902, the means for controlling the direction from which themedication exits the flexible tubular member 108′ and is introduced tothe nasal cavity may include the opening 160 having a particulardirectional shape such that the shape of the opening 160 directs theoutflow of medication in a direction towards the inflatable member 116.Referring specifically to FIG. 9B, a further alternative means forcontrolling the direction from which the medication exits the flexibletubular member 108′ and is introduced to the nasal cavity includes theopening 160 adjacent the expandable member 116, wherein a deflector isomitted. The expandable member 116 may optionally have an inflatedconfiguration such that its shape includes a narrower width (or crosssectional profile) proximal the flexible tubular member 108′ and a widerwidth (or cross sectional profile) distal the flexible tubular member108′. This may allow the opening 160, which is adjacent the narrowerwidth portion of the flexible tubular member 108′ to have aperpendicular orientation within and the flexible tubular member 108′such that upon medication exiting the opening 160, the medicationcontacts the wider width portion of the flexible tubular member 108′.And after the level of the pool of medication rises above the opening160 distal the expandable member 116, the additional medication exitingthe opening enters directing in the pool.

Referring to step 720 of FIG. 7, it may be preferable for the medicationto remain within the nasal cavity and contact the mucosa overlaying theSPG, as well as the SPG, for a predetermined period of time (e.g., about20 minutes), as discussed above. Referring to step 730, upon the SPGbeing directly exposed to the medication for the desired period, themedication is removed from the nasal cavity by suctioning the medicationthrough the opening 160 with an auxiliary syringe. Once the medicationis removed, the expandable member 116 may be collapsed by retracting theplunger 164 of the syringe 112, as depicted in step 728 of FIG. 7. Asset forth in step 732, after the medication is removed and theexpandable member 116 is collapsed, the surgical device 100 may beremoved from the nasal cavity.

The procedure discussed above with respect to FIG. 7 performs asphenopalatine ganglion block for one SPG located on one (i.e., left orright) side of the patient's head. Upon completing the sphenopalatineganglion block for one side of the head, the same procedure can berepeated by inserting the distal end of the elongated flexible tubularmember 108 into the patient's other nostril and applying the medicationto the other SPG.

Referring to FIG. 10A, there is depicted an alternative embodiment ofthe surgical device 100 depicted in FIGS. 1-4. As discussed above thesurgical device 100 depicted in FIGS. 1-4 includes expandable member 116located at, adjacent to or toward the distal end 124 of the flexibletubular member 108. As depicted in FIG. 10A, the surgical device 100′may include a second expandable member 118 disposed proximally ofexpandable member 116 and the opening 160. Again, the expandable member116 of the surgical device 100 allows the clinician to create a blockagewithin the patient's throat and fill a portion of the nasal cavity suchthat medication directly contacts the mucosa overlaying the SPG for asustained period while preventing the medication from flowing down thepatient's throat. The second expandable member 118 may be used toprevent the medication from exiting the patient's nostril. As depictedin FIG. 11A and FIG. 12, after introducing the surgical device 100′through the patient's nostril, the expandable member 116 is disposedadjacent the choana, the expandable member 116 is inflated, andmedication is introduced to patient's nasal cavity through the opening160, and the medication collects above the expandable member 116 andadjacent the SPG. After or in conjunction with introducing the surgicaldevice 100′ through the patient's nostril and/or locating the expandablemember 116 the choana, the second expandable member 118 is disposedadjacent the exterior of the patient's nostril or in the patient'snostril, and the second expandable member 118 is inflated. Inflating theexpandable member 116 adjacent the choana and the second expandablemember 118 adjacent patient's nostril allows the medication to collectbetween the two expandable members 116, 118 while preventing themedication from flowing down the patient's throat and escaping throughthe patient's nostril, particularly if the patient moves his/her headand/or when the patient's head is not in the most desirable orientation.

The second expandable member 118 may be coupled to the same inflationlumen and inflation port used to inflate expandable member 116 so thatthe two expandable members 116, 118 are inflated simultaneously. Or thesurgical device 100′ may include a second inflation lumen (not shown)and/or a second inflation port (not shown) to inflate the secondexpandable member 118 separately from expandable member 116. Thedistance from the entry of a patient's nostril to a patient's choana mayvary among patients. Accordingly, it may be desirable to have a meansfor adjusting the distance between the two expandable members 116, 118.For example, it may be desirable to have a means for sliding the secondexpandable member 118 over the elongated flexible tubular member 108.Sliding the second expandable member 118 over the elongated flexibletubular member 108 relative to expandable member 116, which may be fixedor slidable, allows a clinician to initially locate the expandablemember 116 adjacent the patient's choana, then insert or place thesecond expandable member 118 adjacent the patient's nostril. Once theexpandable members 116, 118 are located in the desired locations, theexpandable members 116, 118 are inflated, thereby forming a snug fit inthe patient's nostril and preventing medication from flowing down thepatient's throat and escaping through the patient's nostril.

Referring to FIG. 10B, there is depicted another alternative embodimentof the surgical device 100 depicted in FIGS. 1-4. In comparison to theembodiment of the surgical device 100′ illustrated in FIG. 10A, thesurgical device 100″ illustrated in FIG. 10B, further includes adelivery device 117 between the expandable members 116, 118 fordelivering the medication. The delivery device 117 may include anexpandable member having a permeable membrane or semi-permeable membranedisposed over the opening 160 such that upon expansion, pores within thepermeable membrane or semi-permeable membrane increase in size and allowthe medication to exit there through. Additionally, the delivery device117 may alternatively include a sponge disposed over opening 160. Asdepicted in FIG. 11B, it may be preferable to locate the surgical deviceof FIG. 10B in the patient's nasal cavity with the expandable member 116disposed adjacent the choana, the delivery device 117 in the patient'snasal cavity adjacent the SPG, and the second expandable member 118disposed adjacent and exterior of the patient's nostril. Once thedelivery device 117 is located adjacent the SPG, the medication isdelivered through the delivery device 117.

For various medical and health-related purposes, there is also apotential need to insure that the surgical device is used only fortreating a single patient and not used for treating multiple patients.Typically, the surgical device may be used on both sides of thepatient's nasal cavity by inserting the surgical device into bothnostrils of the patient, wherein the treatment of each side of the nasalcavity for the same patient may be considered a separate procedure. Asdiscussed above, the LED is battery powered. One method of insuring thatthe surgical device is only used on a single patient is to preclude theuse of the LED, and therefore, prevent the surgical device's ability totransilluminate through tissue after a predetermined time. Precludingthe use of the LED may be assured by depleting the batteries powersupply. As discussed above, a typical sphenopalatine ganglion blockprocedure may take between 5 minutes and 35 minutes for one side of thenasal cavity. That is, it may take between 10 minutes and 70 minutes fora clinician to complete a sphenopalatine ganglion block procedure forboth sides of the patient's nasal cavity. Accordingly, if the batterypower is depleted after such predetermined time, then the LED will beinoperable.

In addition to insuring that the battery power is depleted after suchpredetermined time, it may also be desirable to prevent the LED fromconsuming any battery power during shipment, which would prematurelyconsume the limited availability of the battery's power. A potentialsolution for solving these two concerns is the inclusion of a pull-taband parallel circuits within the surgical device. Referring to FIG. 17,there is depicted the proximal end of a pull tab 1602 inserted into thehandle 1602 of the surgical device in an un-pulled position. Referringto FIG. 18, the distal end of the pull tab 1602 is disposed adjacent thebattery terminal or between the battery terminals to interrupt andmaintain an open circuit as schematically depicted in FIG. 19A.

Referring to FIGS. 19A, 19B, and 19C, there is shown a schematic diagramof a circuit 1900 in three different phases. The circuit 1900 has twopotential circuit paths: one potential circuit path includes deliveringpower from the battery 1904 to the resister 1908; and the otherpotential circuit path includes delivering power from the battery 1904to the resister LED, which is indicated as item 216 in these figures.During shipment of the surgical device 100, it is desirable that bothcircuit paths remain open. Referring to FIG. 19A, inclusion of the pulltab 1602 in an un-pulled position insures that both circuit paths willbe remain open, thereby preventing the resistor 1908 and the LED 216from drawing power from the battery. Also depicted within the circuit ofFIG. 19A, the switch 128 is in an open position because it is notdepressed. Referring to FIG. 19B, the switch 128 is still in an openposition. The circuit path to the LED 216 is, therefore, open in bothFIGS. 19A and 19B. The circuit path to the resistor 1908 is open in FIG.19A, but the circuit path to the resistor 1908 is closed in FIG. 19Bbecause the pull tab 1602 has been removed and illustrated in apulled-position. Once the pull tab 1602 is removed and/or in a pulledposition, the resistor 1908 begins drawing power from the battery 1904.The power capacity of the battery 1904 and/or the size of the resistor1908 are designed or configured to utilize all of the battery's powercapacity within a predetermined time, thereby preventing a clinicianfrom performing more than one sphenopalatine ganglion block procedure ona single patient. For example, referring to FIG. 19C, once the switch128 is in a closed position, the circuit path to the LED 1816 is alsoclosed. Accordingly, this figure illustrates both circuit paths inclosed positions—the battery 1904 is delivering power to the resister1808 and to the LED 1816.

An alternative means of depleting the battery power in a predeterminedtime includes a one way switch for the LED such that LED always remainson, thereby continuously draining battery power. If this means is used,the power supply and/or resistance of the LED would be designed todeplete the battery power within a predetermined time.

Referring to FIGS. 20A and 20B, there is depicted a further alternativeembodiment of the surgical device 100′″ depicted in FIGS. 1-4. Incomparison to the embodiment of the surgical device 100 illustrated inFIGS. 1-4, the surgical device 100′″ illustrated in FIGS. 20A and 20Balso includes a stabilizer 2004 slidably disposed over the flexibletubular member 108 between the distal end 144 of the handle 104 and theexpandable member 116. As will be discussed in more detail below, thestabilizer 2004 is able to slide over and relative to the flexibletubular member 108. For instance, FIG. 20A illustrates the stabilizer2004 adjacent to and/or distal the distal end 144 of the handle 104 (orat and/or adjacent the proximal end of the flexible tubular member 108)and proximal the expandable member 116 (or proximal the distal end ofthe flexible tubular member 108). FIG. 20B, however, illustrates thestabilizer 2004 distally of the distal end 144 of the handle 104 (ordistally of the proximal end of the flexible tubular member 108) andmore proximal the expandable member 116 (or more proximal the distal endof the flexible tubular member 108), in comparison the position of thestabilizer 2004 depicted in FIG. 20A.

For example, referring to FIG. 21A, upon placing the surgical device100′″ in the nasal cavity such that the expandable member 116 is locatedat the desired position, namely in the nasopharynx adjacent the choana,and the expandable member 116 is expanded adjacent the choana, thelocation of the stabilizer 2004 is initially distal the patient's nose.Referring to FIG. 21B, after placing the surgical device 100′″ in thenasal cavity and expanding the expandable member 116 adjacent thechoana, the clinician may slide the stabilizer 2004 along the elongatedflexible tubular member 108 such that the stabilizer 2004 contacts thepatient's nose or anterior naris or is located adjacent to either thepatient's nose or anterior naris. Placing the stabilizer 2004 against oradjacent the patient's nose or anterior naris assists in securing theexpandable member 116 in its desired location, namely adjacent thechoana in its inflated state. For example, when the expandable member116 is disposed adjacent the choana in its inflated state, thestabilizer 2004 provides anterior traction on the seated expandablemember 116 from exterior the patient's nasal cavity, nose and/oranterior naris. That is, the stabilizer 2004 aids in retaining theexpandable member 116 (and/or the expandable member 118) in positionwhile the clinician is performing the sphenopalatine ganglion blockprocedure. Specifically, the stabilizer 2004 may prevent the surgicaldevice 100′″ or a portion thereof, namely the flexible tubular member108 (or a portion thereof) and/or the expandable member 116 from movingand/or becoming unseated during inflation in the event the patientmoves. For example, rapid or quick movement of the patient's head, suchas movement resulting from a cough or a sneeze, may cause the expandablemember 116 to also move. In the event of such movement, the seal formedby the expandable member 116 against the choana may become unseated orunstable, thereby allowing the fluid (e.g., medication) located abovethe expandable member 116 to leak past the expandable member 116 andinto the patient's throat.

Continuing to refer to FIG. 21B, the configuration of the stabilizer2004 depicted in this figure is such that it remains completely outsidethe patient's nose and does not enter the patient's nostril or nasalvestibule. However, the configuration of the stabilizer could bedesigned to be placed partially or completely inside the patient'snostril. For example, the stabilizer could be designed such that oneportion of the stabilizer is inside the patient's nostril and anotherportion of the stabilizer is outside the patient's nose.

Referring to FIGS. 22A-22D, the stabilizer 2004 depicted in thesefigures is configured to remain completely outside the patient's nosewithout any portion thereof entering the patient's nostril or nasalvestibule. Stabilizer 2004 has a proximal portion 2012, a distal portion2008 and a lumen 2016 extending along the longitudinal axis of thestabilizer 2004 and through both the proximal portion 2012 and thedistal portion 2008. That is, the lumen 2016 extends from the proximalend of the proximal portion 2012 to the distal end of the distal portion2008 of the stabilizer 2004.

The proximal portion 2012 of the stabilizer 2004 has a smallercross-sectional profile in comparison to the distal portion 2008,although the relative sizes of such cross-sectional profiles may bereversed or the same. Referring to FIGS. 22B & 22C, the cross-sectionalprofile of the distal portion 2008 may have a generally saddle shape.For example, the distal portion 2008 may have a top portion 2020, abottom portion 2024, and two side portions 2028, 2032. And the lengthbetween the top portion 2020 and bottom portion 2024 may be less thanthe length between the two side portions 2028, 2032. Also, the topportion 2020 and bottom portion 2024 may each have a convex shape, andthe two side portions 2028, 2032 may each have concave shapes, therebycreating a saddle-shaped cross sectional profile for the distal portion2008 of the stabilizer 2004.

The concave shaped side portions 2028, 2032 also create indentationsthat allow the clinician to easily grasp the stabilizer 2004 withhis/her finger(s) and/or thumb. The stabilizer 2004 may be constructedof a flexible and/or polymeric material, such as silicone. Upon aclinician grasping the flexible stabilizer 2004 and squeezing it on theside portions 2028, 2032, as illustrated by the arrows depicted in FIG.22C, the stabilizer 2004 is forced into and enters a compressed state.And when the clinician releases the stabilizer 2004, it returns to anuncompressed state, as depicted in FIG. 22B.

As mentioned above, the stabilizer 2004 comprises a lumen 2016 extendingalong the longitudinal axis of the stabilizer 2004 and through both theproximal portion 2012 and the distal portion 2008 such that the lumen2016 extends from the proximal end of the proximal portion 2012 to thedistal end of the distal portion 2008 of the stabilizer 2004. Thecross-sectional profile of the lumen 2016 may vary or remain constantfrom its proximal end to its distal end. For example, the shape of thelumen at and/or towards its proximal end may be circular, while theshape of the lumen at and/or towards its distal end may be oval or viceversa. For example, FIG. 22B depicts the cross-sectional shape of thelumen 2016 as oval at the distal portion 2008 of the stabilizer 2004,and FIG. 22C depicts the cross-sectional shape of the lumen 2016 ascircular at the distal portion 2008. Similarly, FIG. 22D depicts thecross-sectional shape of the lumen 2016 as circular at the proximalportion 2012.

Regardless of whether the cross-sectional shape of the lumen 2016 iscircular or oval, the circumference of such circle or oval is greaterthan the circumference of the flexible tubular member 108 extendingthrough the lumen 2016. The size of the circumference of the lumen 2016being greater than the size of the circumference of the flexible tubularmember 108 insures that the stabilizer 2004 can slide relative to theflexible tubular member 108. Even though the circumference of the lumen2016 is greater that of the flexible tubular member 108, the lumen 2016contacts the flexible tubular member 108 in either its compressed stateor its uncompressed state. For example, assuming that thecross-sectional shape of the lumen 2016 is oval at its distal end andtransitions to a circular shape at its proximal end, as illustrated inFIGS. 22B and 22D, one or more portions of the lumen 2016 contacts oneor more portions the flexible tubular member 108, when the stabilizer2004 is in an uncompressed state. And upon a clinician grasping theflexible stabilizer 2004 and squeezing it on the side portions 2028,2032, the stabilizer 2004 is forced into and enters an compressed state,as illustrated in an FIG. 22C, such that no portion of the lumen 2016contacts any portion the flexible tubular member 108 when the stabilizer2004 is in a compressed state. When the stabilizer 2004 is in acompressed state, the stabilizer is able to slide over the flexibletubular member 108, and when the stabilizer 2004 is in an uncompressedstate, the stabilizer 2004 is unable to slide over the flexible tubularmember 108 due to the frictionally contact between the stabilizer 2004and the flexible tubular member 108. Upon release of the stabilizer 2004by the clinician, the stabilizer 2004 returns to an uncompressed state,and the shape of the lumen 2016 returns to that of the oval depicted inFIG. 22B, thereby creating contact between the stabilizer 2004 and theflexible tubular member 108 and preventing sliding of the stabilizer2004 over the flexible tubular member 108 due to the friction betweenthe two components.

The surface of the distal end of the distal portion 2008 of thestabilizer 2004 is flat or relatively flat. The flat shape of the distalend of the distal portion 2008 insures that the stabilizer 2004 remainscompletely outside the patient's nose upon sliding it adjacent thereto.Also, the stabilizer 2004 may comprise a gusset 2006 that buttresses thedistal portion 2008 of the stabilizer 2004, particularly the proximalface 2036 of the distal portion 2008

Referring to FIG. 23, there is depicted a flow chart 700″ representingat least some of the steps of an alternative method of performing thesurgical technique of performing using the alternative embodiment of thesurgical device 100′″ of the present disclosure. The flow chart 700″depicted in FIG. 23 is similar to the flow chart depicted in FIG. 7,with the exception that the flow chart 700″ depicted in FIG. 23 alsoincludes one or both of the following steps: step 715, which includessliding the stabilizer 2004 adjacent and/or against the patient's nose(after step 712 and prior to step 716); and step 726, which includessliding the stabilizer 2004 away from the nose (after step 724 and priorto step 728). Although steps 715 and 726, as well as the other steps,are depicted in certain locations within the flowchart, these steps donot necessarily need to be performed in this particular order during thesurgical procedure. For example, steps 715 and 726 may be performedprior and/or after other steps depicted within the process. Regardlessof where steps 715 and 726 are performed during the sphenopalatineganglion block procedure, utilizing the stabilizer 2004 aids in holdingthe expandable member 116 (and/or the expandable member 118) in positionwhile the clinician is performing this surgical procedure.

The foregoing discussion has been presented for purposes of illustrationand description. The foregoing is not intended to limit the disclosureto the form or forms disclosed herein. In the foregoing Summary forexample, various features of the disclosure are grouped together in oneor more aspects, embodiments, and/or configurations for the purpose ofstreamlining the disclosure. The features of the aspects, embodiments,and/or configurations of the disclosure may be combined in alternateaspects, embodiments, and/or configurations other than those discussedabove. For example, the device(s) described in the present disclosuremay be used in conjunction with other medical devices. Specifically,prior to inserting the device(s), which are described in the presentdisclosure into the patient's nasal cavity, the clinician may first usean endoscope or other medical device to perform a nasal examination andinspect the patient's nasal cavity and insure that nasal mucosa isintact and there are not any obvious internal anatomic obstructionwithin the patient's nasal cavity that would prevent the passage of thedevice described herein, which may have a diameter of about 4 mm. Thismethod of disclosure is not to be interpreted as reflecting an intentionthat the claims require more features than are expressly recited in eachclaim. Rather, as the following claims reflect, inventive aspects lie inless than all features of a single foregoing disclosed aspect,embodiment, and/or configuration. Thus, the following claims are herebyincorporated into this Detailed Description, with each claim standing onits own as a separate preferred embodiment of the disclosure.

Moreover, though the description has included description of one or moreaspects, embodiments, and/or configurations and certain variations andmodifications, other variations, combinations, and modifications arewithin the scope of the disclosure, e.g., as may be within the skill andknowledge of those in the art, after understanding the presentdisclosure. It is intended to obtain rights which include alternativeaspects, embodiments, and/or configurations to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. A method for delivering a medication to asphenopalatine ganglion of a patient, the method comprising the stepsof: (a) inserting a portion of a device into a nasal cavity of a patientthrough a nostril, the device comprising: a handle comprising a proximalend and a distal end; an inflation device at least partially andintegrally disposed within the handle; a flexible tubular memberextending from the distal end of the handle, the flexible tubular membercomprising a proximal end, a distal end, an inflation lumen coupled tothe inflation device and extending from the proximal end of the flexibletubular member, and a second lumen extending from the proximal end ofthe flexible tubular member to a medication port; an expandable memberattached to the flexible tubular member, the expandable membercomprising a proximal end and a distal end, wherein the inflation lumenopens, via an inflation port, into the expandable member, wherein themedication port is disposed proximally of the proximal end of theexpandable member; an illumination device disposed distally of theexpandable member; and a non-inflatable stabilizer slidably coupled tothe flexible tubular member, wherein the non-inflatable stabilizer iscapable of sliding along the flexible tubular member between the handleand the expandable member; (b) activating the illumination device andviewing light emitted from the illumination device through a portion ofthe patient's soft palate; (c) expanding, using the inflation lumen, theexpandable member adjacent to the patient's choana; (d) sliding thenon-inflatable stabilizer toward the patient's nose; (e) introducing anamount of medication into the nasal cavity through the medication port,such that the medication rises to a level and contacts at least aportion of mucosa overlaying a sphenopalatine ganglion of the patientfor a period of 5 minutes to 35 minutes; (f) collapsing the expandablemember; and (g) removing the device from the nasal cavity.
 2. The methodof claim 1, further comprising the step of sliding the non-inflatablestabilizer away from the patient's nose.
 3. The method of claim 1,further comprising the step of removing at least a portion of themedication through the medication port in the flexible tubular member.4. The method of claim 1, further comprising the step of inserting thedevice into a second portion of the nasal cavity of the patient througha second nostril and performing steps (b) through (g).
 5. The method ofclaim 1, wherein the level of medication is maintained for 10 minutes to30 minutes.
 6. The method of claim 5, wherein the level of medication ismaintained for 15 minutes to 25 minutes.
 7. The method of claim 6,wherein the level of medication is maintained for at least 20 minutes.8. The method of claim 1, wherein the amount of the medicationintroduced to the nasal cavity is between 2 milliliters to 15milliliters.
 9. The method of claim 1, wherein the amount of themedication introduced to the nasal cavity is between 5 milliliters to 10milliliters.
 10. The method of claim 1, wherein the step of insertingthe device into the nasal cavity comprises introducing the device into achannel below an inferior turbinate and above a hard palate.
 11. Themethod of claim 1, wherein the step of expanding the expandable memberadjacent to the patient's choana comprises placing the expandable memberin the patient's nasopharynx.
 12. The method of claim 1, wherein thestep of introducing an amount of medication into the nasal cavitycomprises actuating an auxiliary syringe coupled to the second lumen.13. The method of claim 1, wherein the non-inflatable stabilizercomprises a lumen capable of having a first configuration and a secondconfiguration.
 14. The method of claim 1, wherein the non-inflatablestabilizer is capable of sliding along the flexible tubular member whenthe lumen has a first configuration and the non-inflatable stabilizer isless capable of sliding along the flexible tubular member when the lumenhas a second configuration.
 15. The method of claim 1, wherein thehandle further comprises a switch for activating the illuminationdevice.